Core Viewpoint - NEFECON (Budesonide Delayed-Release Capsules) has been included in the "Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (Preliminary Version)" in China, marking it as the only IgA nephropathy treatment recommended by both domestic and international guidelines, solidifying its position as a cornerstone therapy for IgA nephropathy patients [1][3]. Group 1: Treatment Guidelines - The guidelines recommend initiating treatment for patients with proteinuria ≥0.5 g/d and suggest kidney biopsy, with treatment goals aimed at reducing proteinuria to <0.5 g/d and maintaining an estimated glomerular filtration rate (eGFR) decline of <1 ml/min annually [2]. - New monitoring for hematuria has been introduced, and interventions targeting immune damage, including reducing pathogenic IgA, are emphasized [2]. - The guidelines advocate for early, cause-targeted, and comprehensive treatment strategies for IgA nephropathy patients, with NEFECON as the preferred treatment option [2][3]. Group 2: Clinical Significance - The inclusion of NEFECON in the guidelines is seen as a significant advancement for clinical practice in China, providing a scientifically backed treatment option for IgA nephropathy patients [3]. - NEFECON is the first and only IgA nephropathy treatment fully approved in China, the US, and Europe, demonstrating significant clinical advantages such as delaying eGFR decline and reducing proteinuria [3][5]. - The NefIgArd Phase III clinical trial showed that NEFECON significantly reduced the risk of kidney function decline by 50% compared to placebo, with a 66% reduction in the Chinese population, potentially delaying the need for dialysis or kidney transplant by 12.8 years [5].

Group 1 - Roche Pharmaceuticals announced an investment of 2.04 billion RMB to establish a biopharmaceutical production base in Shanghai, aimed at enhancing its supply chain and local production in China, with completion expected in 2029 and production starting in 2031 [1] - Hengrui Medicine's application for the market approval of its CDK4/6 inhibitor, Hydroxyethyl Sulfonate Darsilil Tablets, has been accepted by the National Medical Products Administration, targeting hormone receptor-positive, HER2-negative early or locally advanced breast cancer [2] - Sanyou Medical plans to establish a joint venture with South Korea's CGBio to research innovative cell biological materials in regenerative medicine, marking a significant step in this field [3] Group 2 - ST Kelly has elected a new chairman, Wang Chong, following the recent resignation of both the chairman and the general manager, with the board voting in favor of the appointment [4] - Yunding New Medicine's core product, Naimu Kang, has received full approval from the National Medical Products Administration for treating primary immunoglobulin A nephropathy in adults, becoming the first and only drug in China approved for this indication [5]

5月7日，港股创新药企云顶新耀（01952）宣布，耐赋康®（布地奈德肠溶胶囊）正式获得国家药品监 督管理局（NMPA）同意，由附条件批准转为完全批准，用于治疗具有疾病进展风险的原发性免疫球蛋 白A肾病（IgAN）成人患者，以减少肾功能损失。新适应症夯实了耐赋康治疗 IgA 肾病一线基石地 位，此次完全批准意味着耐赋康®临床研究的完整数据已获通过，成为国内首个且唯一获得NMPA完全 批准的IgA肾病对因治疗药物。 云顶新耀首席执行官罗永庆表示："此次完全批准取消了对蛋白尿水平的限制，这将推动耐赋康®从改 变治疗格局走向重塑治疗标准，延缓IgA肾病患者肾功能衰退，更好地满足长期未被满足的临床需求， 使更多患者获益。新适应症的获批充分验证了耐赋康®的临床疗效与安全性，为医生提供了更加坚实的 治疗决策依据，使其成为了中国首个且目前唯一获得NMPA完全批准的IgA肾病对因治疗药物。" 耐赋康®在获得完全批准后，其适用人群将大幅扩展，随着临床需求激增，医保逐步放量、权威指南的 推荐以及海外市场的加速拓展，多重因素共同推动其市场渗透力和销售增长。作为一款具有显著临床价 值的创新药物，耐赋康®的普及不仅将优化患者治疗路径，也 ...

智通财经APP获悉，4月30日，云顶新耀(01952)今日宣布，中国香港卫生署已正式批准伊曲莫德 (VELSIPITY®，etrasimod)用于治疗中重度活动性溃疡性结肠炎(UC)成人患者的新药上市许可申请。继 中国澳门和新加坡之后，中国香港成为伊曲莫德在云顶新耀授权区域内第三个获批的地区。2024年12 月，伊曲莫德(维适平TM)的新药上市申请获得中国国家药品监督管理局的正式受理。 伊曲莫德是一款每日一次口服的一线先进疗法，不仅使用方便、疗效佳，而且具有良好的安全性特征。 此次获批是基于ELEVATE UC III期注册研究(ELEVATE UC 52和ELEVATE UC 12)的结果。这两项随 机、双盲、安慰剂对照研究均达到了所有主要和关键次要终点，安全性特征与既往研究一致。此前，伊 曲莫德已被纳入2024年美国胃肠病学协会(AGA)临床实践指南, 作为溃疡性结肠炎的一线治疗。 云顶新耀首席执行官罗永庆表示："非常高兴看到伊曲莫德的新药上市申请在中国香港获批。2022年， 中国的溃疡性结肠炎患者数量约为60万人，预计到2030年将达到100万人，存在迫切且巨大的未被满足 的临床需求。我们始终致力于提升 ...

Financial Performance - In 2024, the company achieved a revenue of RMB 706.7 million, exceeding the target of RMB 700 million, reflecting strong operational efficiency and the effectiveness of its dual-driven growth strategy[8] - Revenue for the year ending December 31, 2024, increased by RMB 580.7 million or 461% to RMB 706.7 million, driven by strong sales of Yijia® and the successful launch of NAI-Fu-Kang® in mainland China[20] - The company recorded revenue of RMB 706.7 million for the year ended December 31, 2024, compared to RMB 125.9 million for the year ended December 31, 2023, representing a significant increase driven by strong sales of Yijia® and Naifukang® in mainland China[70] - The company’s stock price increased by 132% in 2024, outperforming the Hang Seng Biotechnology Index, which fell by nearly 16%[7] Product Development and Launches - The innovative drug, Renfu Kang®, was successfully launched in mainland China in May 2024, marking a significant advancement in the treatment of IgA nephropathy, with an estimated 5 million patients benefiting from improved affordability due to its inclusion in the National Medical Insurance Drug List[7] - The company’s best-in-class drug, Velsipity®, was approved in Macau in April 2024 and successfully commercialized, with plans for a new drug application in mainland China expected to be approved by 2026[11] - NEFECON® (Budesonide) is the first drug globally for the treatment of IgA nephropathy, showing a 50% reduction in kidney function decline and a 66% delay in kidney function deterioration in the Chinese population[22] - NEFECON® received approval from the NMPA in November 2023 and is expected to launch in mainland China in May 2024[22] - The company’s innovative drug Nephrocor® was officially launched in mainland China in May 2024, addressing the urgent treatment needs of approximately 5 million IgA nephropathy patients[57] Clinical Trials and Research - The company is advancing its self-developed mRNA product pipeline, with the personalized tumor vaccine EVM16 set to initiate a clinical trial in August 2024, aiming to evaluate safety, tolerability, immunogenicity, and preliminary efficacy[12] - The company plans to announce one-year follow-up data from the 1b/2a clinical trial of EVER001 in 2025[30] - The clinical application evaluation project for Irasuromycin was launched on September 23, 2023, and completed data collection in November 2024, involving 3,369 cases from 231 hospitals with an overall efficacy rate of 91.1% after 3 days of treatment[32] - The company has launched a clinical trial for its personalized tumor vaccine EVM16, marking a significant milestone in its mRNA product pipeline[45] Market Strategy and Expansion - The company is deepening its penetration into 300 core hospitals and collaborating with Contract Sales Organizations (CSOs) to expand patient access beyond core hospitals[9] - The company’s strategic expansion in Asia includes obtaining new drug approvals in Singapore, Hong Kong, Taiwan, and South Korea for Renfu Kang®[8] - The company aims to leverage its first-mover advantage in the mainland China market while actively expanding into other Asian markets, including Taiwan and South Korea[63] - The company’s innovative market strategy includes leveraging online medical platforms alongside traditional hospital channels[57] Financial Health and Expenses - The gross margin improved from 72.7% for the year ending December 31, 2023, to 74.6% for the year ending December 31, 2024, primarily due to the commercialization of NAI-Fu-Kang® and product cost optimization[20] - Research and development expenses for the year ending December 31, 2024, were RMB 528.0 million, slightly down from RMB 540.1 million for the previous year, reflecting the company's commitment to strategic R&D investments[20] - Distribution and selling expenses increased significantly from RMB 231.4 million for the year ended December 31, 2023, to RMB 508.1 million for the year ended December 31, 2024, due to expanded commercialization efforts[78] - The operating loss for the year ended December 31, 2024, was RMB 1,117.0 million, compared to RMB 932.7 million for the year ended December 31, 2023[70] Regulatory Approvals and Compliance - The company has received FDA approval for its generic tumor-associated antigen vaccine's IND application, marking a significant milestone in its mRNA oncology innovation efforts[14] - NEFECON® was granted a seven-year exclusivity period as an orphan drug by the FDA, extending until December 2030[22] - The company has complied with all relevant laws and regulations without any significant violations for the year ended December 31, 2024[124] Shareholder Information and Corporate Governance - As of December 31, 2024, the total number of employees in the group is 665, an increase from 432 in 2023, with 98.6% of sales coming from the largest customer[125][130] - The company has not declared any final dividends for the year ended December 31, 2024, nor for the year ended December 31, 2023[143] - The shareholding structure indicates that the majority of shares are held by a few key stakeholders, highlighting potential concentration of ownership[163] - The company aims to incentivize key employees through its stock option plans to drive growth and development[166]

Core Insights - The company, CloudTop New Drug-B (01952), has achieved significant growth in the innovative drug market, with a revenue increase of 461.16% year-on-year, reaching 707 million yuan in 2024, marking its first successful financial year and indicating a potential transition to a new stage of maturity [1][2] - The dual strategy of "independent research and development + authorized introduction" has allowed the company to target high-potential, low-competition areas, leading to efficient commercialization of differentiated innovative results [1][2] - The successful commercialization of key products, such as NAIFUKANG® and YIJIA®, has been crucial for the company's growth, with both products generating significant sales revenue shortly after their market introduction [2][3] Financial Performance - In 2024, the company reported a revenue of 707 million yuan, a substantial increase of 461.16% compared to the previous year [1] - NAIFUKANG® generated 353 million yuan in sales within just seven months of its launch, while YIJIA® achieved sales of 353 million yuan in 2024, reflecting a year-on-year growth of 256% [2] Product Development - The company is advancing its pipeline with key products like Yiqiumode, which is expected to reach peak sales of 2 billion yuan and is anticipated to be a significant part of the product line [3] - The company is also expanding into AI-driven drug development, with its first AI-driven mRNA personalized cancer vaccine, EVM16, completing its first patient dosing, marking a significant step in clinical validation [3] Market Position and Future Outlook - The company is positioned to replicate the success of other 18A companies that have transitioned to maturity, with expectations of continued stock price growth and market recognition [4] - Recent reports have indicated a substantial increase in the company's target price by 133% to 70 HKD, reflecting the market's recognition of its research and development value [4]

Group 1 - The Hang Seng Healthcare Index (HSHCI) has seen a strong increase of 1.80%, with notable gains from companies such as Lepu Biopharma-B (up 16.56%) and Zai Lab (up 10.27%) [1] - The Hang Seng Medical ETF (513060) has risen by 2.11%, marking its third consecutive increase, with a trading volume of 4.69 billion yuan [1][2] - The second Boao Lecheng Stem Cell Conference has opened, marking a new phase of standardized and high-quality development in China's stem cell industry [2] Group 2 - Financial analysts predict that the approval and implementation of more projects in the stem cell sector will lead to advanced treatment methods benefiting the public [2] - The domestic medical innovation industry is expected to experience multiple growth opportunities, particularly for companies with true innovation capabilities in new drug development [2] - The Hang Seng Medical ETF has seen a significant growth in scale, increasing by 34.09 billion yuan over the past year, ranking in the top third among comparable funds [2] Group 3 - Since its inception, the Hang Seng Medical ETF has achieved a maximum monthly return of 28.34% and an average monthly return of 7.00% [3] - The ETF has outperformed its benchmark with an annualized excess return of 2.02% over the past year [3] - The ETF's management fee is 0.50%, and the custody fee is 0.15% [3] Group 4 - The tracking error of the Hang Seng Medical ETF is 0.033%, the highest tracking precision among comparable funds [4] - The latest price-to-earnings ratio (PE-TTM) of the Hang Seng Medical Healthcare Index is 24.97, indicating it is at a historical low compared to the past year [4] - The top ten weighted stocks in the Hang Seng Medical Healthcare Index account for 55.64% of the index, with companies like WuXi Biologics and BeiGene among the leaders [4][6]

交银国际研究 公司更新 | 医药 | 收盘价 | | 目标价 | 潜在涨幅 | 2025 年 3 月 27 日 | | --- | --- | --- | --- | --- | --- | | 港元 | | 54.20 | 港元 65.00↑ | +19.9% | | | 云顶新耀 (1952 HK) | | | | | | 2024 年实现商业化层面盈利，耐赋康快速渗透目标市场，上调目标价 | 财务数据一览 | | | | | | | --- | --- | --- | --- | --- | --- | | 年结12月31日 | 2023 | 2024 | 2025E | 2026E | 2027E | | 收入 (百万人民币) | 126 | 707 | 1,689 | 2,819 | 3,908 | | 同比增长 (%) | 884.5 | 461.2 | 138.9 | 66.9 | 38.6 | | 净利润 (百万人民币) | (844) | (1,041) | (264) | 311 | 794 | | 每股盈利 (人民币) | (2.80) | (3.24) | (0.81) | 0.96 ...

交银国际研究 公司更新 | 医药 | 收盘价 | | 目标价 | 潜在涨幅 | 2025 年 3 月 27 日 | | --- | --- | --- | --- | --- | --- | | 港元 | | 54.20 | 港元 65.00↑ | +19.9% | | | 云顶新耀 (1952 HK) | | | | | | 2024 年实现商业化层面盈利，耐赋康快速渗透目标市场，上调目标价 | 财务数据一览 | | | | | | | --- | --- | --- | --- | --- | --- | | 年结12月31日 | 2023 | 2024 | 2025E | 2026E | 2027E | | 收入 (百万人民币) | 126 | 707 | 1,689 | 2,819 | 3,908 | | 同比增长 (%) | 884.5 | 461.2 | 138.9 | 66.9 | 38.6 | | 净利润 (百万人民币) | (844) | (1,041) | (264) | 311 | 794 | | 每股盈利 (人民币) | (2.80) | (3.24) | (0.81) | 0.96 ...

Everest Medicines (01952) H2 2024 Earnings Call March 26, 2025 10:59 AM ET Company Participants Leah Liu - VP of Corporate AffairsRogers Yongqing Luo - Member of Board of Directors & CEOIan Woo - Executive Director, President and CEOSandra Zeng - Chief Medical OfficerWei Jennifer Yang - Chief Scientific Officer Conference Call Participants Linhai Percy Zhao - Equity Research Analyst Operator Good morning or good evening. Welcome to Everest Medicines Full Year twenty twenty four Financial Results Conference ...